Shots: The US FDA has approved Soaan for the treatment of heart failure & renal disease. The therapy offers a new treatment option for heart failure patients who experience persistent […]readmore
Tags : approval
Shots: The conditional approval is based on results from a P-II trial in China evaluating the safety & efficacy of Brukinsa in patients with WM who have received at least […]readmore
Shots: The EC approval is based on a P-III TERIKIDS study evaluating Aubagioin vs PBO in 166 pediatric patients aged 10-17yrs. with RRMS across 22 countries globally, where a screening […]readmore
Shots: The full FDA approval is based on data from 2 clinical trials i.e., P-I EXPLORER & P-II PATHFINDER trial evaluating the efficacy of Ayvakit (200 mg, PO, qd) in […]readmore
Shots: The US FDA has approved Rezipres for the treatment of hypotension that occurs in the setting of anesthesia Rezipres is a sulfite-free formulation that has been sold successfully in […]readmore
Shots: The US FDA has approved the NDA of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) for children aged 3 […]readmore
Regulatory
Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Receives the US FDA’s Approval
Shots: The approval is based on a P-III study evaluating the safety, PK & efficacy of Trikafta in 66 children aged 6-11yrs. old with CF with either two copies of […]readmore
Shots: The approval is based in the clinical program including P-I & II trials, and three P-III trials evaluating the safety & immunogenicity of Prevnar 20 in adults aged ≥18yrs. […]readmore
In an interview with PharmaShots, Mike Crichton, Senior Vice President, Global Therapy Area Head, Specialty & Primary Care at GSK shares his views on the European Commission’s approval of Benlysta […]readmore
Shots: The approval is based on data from two P-III studies i.e SELECT-PsA 1 & 2 evaluating the safety & efficacy of Rinvoq vs PBO in 2,000+ patients with active […]readmore